A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: IBI321

• Registration Number: NCT05172856
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Study First Posted: 2021-12-29
• Last Update Posted: 2021-12-29
• Study Start: 2022-03-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Male or female subjects ≥18 years and ≤75 years.
3. At least one measurable lesion per RECIST version 1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
5. Life expectancy of ≥ 12 weeks.
6. Adequate hematologic and end organ function

Exclusion Criteria

1. Failure to recover from adverse events from the most recent anti-tumor treatments
2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
3. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
4. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
5. Pregnancy, lactation, breastfeeding.
6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI321 in advanced solid tumors	IBI321	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.	From Baseline until disease progression (up to 2 years)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From Day 1 to up to 2 years
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.	From Baseline until disease progression (up to 2 years)
Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0	From Day 1 to up to 2 years
Area Under the Concentration-Time Curve (AUC) of IBI321	From Day 1 up to 2 years
Maximum Serum Concentration (Cmax) of IBI321	From Day 1 up to 2 years
Minimum Serum Concentration (Cmin) of IBI321	From Day 1 up to 2 years
Clearance (CL) of IBI321	From Day 1 up to 2 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321	From Day 1 up to 2 years
Percentage of Participants with Neutralizing Antibody (Nab) to IBI321	From Day 1 up to 2 years

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China